Nitric Oxide Supplementation in Argininosuccinic Aciduria
Completed · Not applicable · Has a placebo group
Conditions studied: Argininosuccinic Aciduria, Argininosuccinate Lyase Deficiency, Urea Cycle Disorders
In brief
This is a study involving a dietary supplement. Patients with argininosuccinic aciduria will be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 2 weeks, and then crossed-over to receive the other treatment for two weeks. The investigators expect to see that : 1) Patients with ASA will have a decreased ability for their arteries to dilate due to nitric oxide deficiency, 2) Treatment of ASA with the nitric oxide supplement will improve the ability of their arteries to dilate, and 3) Through the testing of subjects' fibroblasts (cells in connective tissue that produce collagen and other fibers), the investigators hope to predict which patients may respond NO supplementation.
Key facts
- Study ID
- NCT02252770
- Run by
- Baylor College of Medicine
- People needed
- 12
- Starts
- 2014-09-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2020-01-18
Who can join
Age: 8 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A confirmed diagnosis of ASA based on biochemical, enzymatic, or genetic testing
- Capable of completing study procedures
- History of compliance with diet and treatment
You may not qualify if…
- An active infection (viral or bacterial), any condition(s) that may precipitate a metabolic decompensation
- A hypersensitivity to nitrite
- A serum creatinine > 1.5 times above the normal
- A clinical or laboratory abnormality of Grade 3 or greater according to the CTCAE V4.0 (except elevations of AST or ALT which are a part of the disease) which in the view of the Investigator compromises safety
Where it is running
- Texas Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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